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United States · US · US:46708-508_013005e8-214b-41dc-b766-c0c57027487c
bromfenac
Orange BookUNIISPLATC S01BC11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeS01BC11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1146708508171 BOTTLE in 1 CARTON (46708-508-17) / 1.7 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
8ECV571Y37
BROMFENAC SODIUM
RxCUI 47364
Orange Book
A210560
AT2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8ECV571Y37",
"rxcui": "47364",
"inchikey": "PPOSVVJOVKVBPW-UHFFFAOYSA-L",
"display_name": "BROMFENAC SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"fa249b9e-931c-454d-ba06-33139d5580e7": {
"match": "brand_token",
"title": "BROMFENAC OPHTHALMIC SOLUTION (BROMFENAC SODIUM) SOLUTION/ DROPS [DR. REDDY'S LABORATORIES INC.]",
"spl_version": "4",
"published_date": "2026-05-07"
}
},
"productid": "46708-508_013005e8-214b-41dc-b766-c0c57027487c",
"productndc": "46708-508",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "210560",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AT2",
"strength": "EQ 0.09% ACID",
"product_no": "001",
"approval_date": "Jun 21, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BROMFENAC SODIUM",
"proprietary_name": "bromfenac",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA210560",
"marketing_category": "ANDA",
"nonproprietary_name": "bromfenac",
"start_marketing_date": "20221110",
"active_numerator_strength": "1.035"
}Related drugs
Other records sharing ATC code S01BC11.
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